*From the Department of General Practice and Social Medicine (Drs. Cloosterman, Bijl-Hofland, and Akkermans), University of Nijmegen, and Department of Pulmonology (Drs. van Herwaarden and Folgering), Medical Centre Dekkerswald, University of Nijmegen, Nijmegen; the Department of Pulmonology (Dr. Elshout), Rijnstate Hospital, Arnhem; and University of Maastricht (Dr. van Schayck), Maastricht, The Netherlands.

Abstract

Background: Some recent studies suggest that
regular β2-agonist use may result in inadequate control
of asthma. It has been hypothesized that this occurs particularly in
allergic asthmatic patients exposed to relevant allergens. Moreover, it
is still unclear whether this occurs during the use of both
short-acting and long-acting β2-agonists.

Methods: Asthmatic patients (n = 145) allergic to house
dust mite (HDM) were randomly allocated to monotherapy with a
short-acting β2-agonist (SA; n = 48), a long-actingβ
2-agonist (LA; n = 50), or placebo (n = 47), double
blind, double dummy. The study covered three periods: (1) a 4-week
run-in period, in which no changes took place; followed by (2)
cessation of treatment with asthma medication including inhaled
corticosteroids, introduction of allergen avoidance measures
(active/placebo treatment) to lower HDM exposure in the active group,
and an 8-week washout period to adjust patients to these changes;
followed by (3) a 12-week study medication period. At the start of the
12-week medication period, and every 4 weeks thereafter,
spirometric measurements (FEV1 and provocative
concentration of histamine causing a 20% fall in FEV1[
PC20]) were performed. Peak flow and asthma symptoms
were recorded daily. Additionally, at the start and every 6 weeks
thereafter, dust samples were collected from mattresses and living room
and bedroom floors to assess HDM (der p 1)
concentrations. Effects on FEV1, PC20, peak
flow, and asthma symptoms were analyzed with repeated-measurement
analysis and corrected for the exposure to HDM allergens.

Results: There were no significant differences among the
three medication groups after 12 weeks for FEV1. However, a
significant decrease in mean FEV1 percent predicted (95%
confidence interval [CI]) was observed within the SA group: − 6.6
(− 10.4 to − 2.8) (p = 0.0002). A decrease in geometric mean
PC20 (95% CI) of − 1.2 (− 1.96 to − 0.44) doubling
concentration was observed within the SA group (p = 0.05). No
significant changes in FEV1 and PC20 were
observed > 12 weeks within the LA group or the placebo group. There
were neither changes in peak flow and asthma symptom scores among the
three medication groups nor within the groups. Moreover, none of the
parameters showed interactive effects with allergen exposure.

Conclusion: There were no significant differences
among the three medication groups for FEV1 and
PC20. The within-treatment group comparison showed a
significant small decline in FEV1 for the SA group (but not
for the LA group), which could indicate that monotherapy with SAs might
have negative effects on FEV1. This was not seen during
regular use of LAs. No clear pathophysiologic mechanism can explain
these findings at the moment. Relatively high or low exposure to
allergens did not alter these findings.

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